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Safer Use of Antipsychotics in Youth (SUAY)

Primary Purpose

Child Behavior Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control - Provider Medication Alert Only
Intervention - Alert + CAP Review AND Enhanced BH Access
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Child Behavior Disorders focused on measuring Youth, Mental Health, Psychotropic, Medication Safety, Quality Improvement

Eligibility Criteria

3 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient is ≥ 3 and < 18 years of age at the time of the encounter at which the study alert fired (index date);
  • Patient is initiating a new episode of outpatient treatment with an antipsychotic medication. (New episodes are defined by no record of an antipsychotic medication being ordered within the health system as part of an outpatient care plan in the prior 180 days);
  • Study service (BH navigation, bridging therapy, CAP consult) ordered in Epic for the patient; (e.g., provider removed antipsychotic order and still ordered study services);

Exclusion Criteria:

  • Patient has a diagnosed psychotic disorder, mania, autism spectrum disorder, or intellectual disability;
  • Patient was enrolled in the SUAY pilot study;
  • The antipsychotic entered is prochlorperazine (Comazol®);
  • An outpatient antipsychotic order is entered by a temporary provider in the health system (e.g., "doc of the day"). Orders placed by temporary providers do not count towards the 180 day medication free period for defining a new episode of care.
  • The antipsychotic order was placed within an urgent care, emergency department, or inpatient setting (to avoid intervening during a crisis). Orders placed in these settings do not count towards the 180 day medication free period for defining a new episode of care.
  • Primary language is not English

Sites / Locations

  • Kaiser Permanente Colorado Institute for Health Research
  • Nationwide Children's Hospital / Partners for Kids
  • Kaiser Permanente Center for Health Research - Northwest
  • Kaiser Permanente Washington Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control - Medication Alert Only

Intervention - Alert + CAP Review AND Enhanced BH Access

Arm Description

The control arm medication alert is a simple text pop-up in the EMR that will inform the prescriber of Choosing Wisely® recommendations developed the American Psychiatric Association regarding antipsychotic medication use in children and adolescents.

The intervention alert prompts the prescriber to keep/remove the antipsychotic order, and/or order any study services: behavioral health navigation, expedited psychotherapy access, virtual consult with a child and adolescent psychiatrist (CAP). Passive case review by the study CAP will occur for all intervention arm cases. A virtual consult will be scheduled if the prescriber ordered it or the CAP needs to discuss the case. The CAP will provide the prescriber with a written summary of his/her review. Following review by the CAP, a navigator reaches out to the eligible intervention arm patient/family to offer extra support. The navigator's role is to (a) provide extra support to facilitate access and engagement in appropriate psychosocial therapies; (b) coordinate short-duration bridging therapy sessions for teens/families not engaged in psychotherapy, when appropriate; and (c) keep the prescriber informed of any clinically relevant updates.

Outcomes

Primary Outcome Measures

Percent of youth with antipsychotic orders at 6 months
Measured by medication orders placed within the health system
Total person-months of antipsychotics ordered for youth
Measured by medication orders placed within the health system

Secondary Outcome Measures

Percent of youth using antipsychotics at 6 months
Measured by medication fill data available to the health system
Total person-months of antipsychotic use by youth
Measured by medication fill data available to the health system
Emergency department/urgent care visit frequency
Measured by utilization data; both for psychiatric crises and for all other reasons
Baseline and follow-up safety assessments
Percentage of patients with BMI measurements, and with safety lab tests ordered and completed at baseline and 3 months
Change to psychotropic medication treatment plan
Percentage of patients with change to psychotropic medication treatment plan following exposure to study algorithm
Behavioral health (BH) navigation acceptance
Percent of intervention arm patients that agree to BH navigation
Use of usual care therapy
Percentage of patients attending two or more system-provided therapy sessions
Use of bridging therapy
Percentage of patients attending two or more study-provided bridging therapy sessions
Use of usual care therapy following bridging therapy
Of patients in study therapy, percentage who subsequently attend two or more system-provided therapy sessions

Full Information

First Posted
February 21, 2018
Last Updated
April 1, 2022
Sponsor
Kaiser Permanente
Collaborators
Nationwide Children's Hospital, Seattle Children's Hospital, University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT03448575
Brief Title
Safer Use of Antipsychotics in Youth
Acronym
SUAY
Official Title
A Targeted Approach To A Safer Use of Antipsychotics In Youth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
December 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Nationwide Children's Hospital, Seattle Children's Hospital, University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study tests the effectiveness of an intervention treatment algorithm vs. usual care control in a practical clinical trial. Control arm providers will receive a standard medication alert in the electronic medical record (EMR) when initiating an antipsychotic prescription for an eligible patient. Intervention arm prescribers will receive an interactive medication alert in the EMR when prescribing for eligible patients and the patient and provider will enter the treatment algorithm (provider - medication alert plus clinical review by a child psychiatrist; patient - offer of personalized behavioral health navigation plus bridging therapy when appropriate). The study aims to recruit 800 eligible patients in 4 health systems.
Detailed Description
SUAY is a practical clinical trial designed to test the effectiveness of an intervention aiming to improve the targeted and safer use of antipsychotic medications by guiding clinician-prescribing behavior of antipsychotics for children aged ≥ 3 and < 18 years and encouraging psychosocial therapy for eligible youth. The intervention includes a medication best practice alert in Epic, consultation with a child and adolescent psychiatrist, and extra support for patients and families to improve behavioral health service access. The trial will be conducted in 4 non-academic health systems. Each health system will randomize prescribers to one of two study arms, intervention and control. During patient encounters, entering an antipsychotic for a potentially eligible patient will cause either the control or intervention medication alert to fire in the electronic medical record. The control arm medication alert will point prescribing clinicians to relevant Choosing Wisely® recommendations. The intervention arm medication alert will inform prescribers that: Antipsychotics are not recommended 1st line treatment for non-psychotic disorders; A child and adolescent psychiatrist (CAP) will review antipsychotic usage by youth; Expedited access to bridging therapy, behavior health navigation, and/or a proactive consultation with a CAP may be ordered. The intervention medication alert will point prescribing clinicians to both Choosing Wisely® recommendations and to SUAY clinical prescribing guidelines. SUAY guidelines were developed by a national expert consensus panel in a prior phase of the study. Analytic data will be collected from automated data sources at the health systems. The primary outcomes are percent of children ordered an antipsychotic medication at 6 months of follow up, and total person-months of antipsychotic orders placed for participants during the study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child Behavior Disorders
Keywords
Youth, Mental Health, Psychotropic, Medication Safety, Quality Improvement

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Providers are preassigned to one of two study arms: usual care control or intervention arm. Patients are assigned to the same arm as the provider triggering the best practice alert and study algorithm.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Waivers of consent have been obtained for providers and for patients/parents/guardians. None are informed of the study design or study activities by arm. The investigator is blind to study arm assignment of providers and patients. Only automated data collection is utilized for this practical trial. Study arm is masked for the programmer/analyst pulling outcomes data from health system records. Study arm will also be masked for study staff verifying study eligibility prior to the official study enrollment. Arm is not masked for study intervention staff (consulting psychiatrists, behavioral health navigators, bridging therapists) since these staff only interact with intervention arm subjects.
Allocation
Randomized
Enrollment
747 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control - Medication Alert Only
Arm Type
Sham Comparator
Arm Description
The control arm medication alert is a simple text pop-up in the EMR that will inform the prescriber of Choosing Wisely® recommendations developed the American Psychiatric Association regarding antipsychotic medication use in children and adolescents.
Arm Title
Intervention - Alert + CAP Review AND Enhanced BH Access
Arm Type
Experimental
Arm Description
The intervention alert prompts the prescriber to keep/remove the antipsychotic order, and/or order any study services: behavioral health navigation, expedited psychotherapy access, virtual consult with a child and adolescent psychiatrist (CAP). Passive case review by the study CAP will occur for all intervention arm cases. A virtual consult will be scheduled if the prescriber ordered it or the CAP needs to discuss the case. The CAP will provide the prescriber with a written summary of his/her review. Following review by the CAP, a navigator reaches out to the eligible intervention arm patient/family to offer extra support. The navigator's role is to (a) provide extra support to facilitate access and engagement in appropriate psychosocial therapies; (b) coordinate short-duration bridging therapy sessions for teens/families not engaged in psychotherapy, when appropriate; and (c) keep the prescriber informed of any clinically relevant updates.
Intervention Type
Other
Intervention Name(s)
Control - Provider Medication Alert Only
Intervention Description
Simple text medication alert referencing Choosing Wisely guidelines.
Intervention Type
Other
Intervention Name(s)
Intervention - Alert + CAP Review AND Enhanced BH Access
Intervention Description
Interactive medication alert referencing SUAY Clinical Guidelines and offering options to keep/remove orders for the antipsychotic, virtual CAP consult, BH navigation for the patient, and access to bridging therapy for the patient.
Primary Outcome Measure Information:
Title
Percent of youth with antipsychotic orders at 6 months
Description
Measured by medication orders placed within the health system
Time Frame
180 day period following index date
Title
Total person-months of antipsychotics ordered for youth
Description
Measured by medication orders placed within the health system
Time Frame
180 day period following index date
Secondary Outcome Measure Information:
Title
Percent of youth using antipsychotics at 6 months
Description
Measured by medication fill data available to the health system
Time Frame
180 day period following index date
Title
Total person-months of antipsychotic use by youth
Description
Measured by medication fill data available to the health system
Time Frame
180 day period following index date
Title
Emergency department/urgent care visit frequency
Description
Measured by utilization data; both for psychiatric crises and for all other reasons
Time Frame
180 day period following index date
Title
Baseline and follow-up safety assessments
Description
Percentage of patients with BMI measurements, and with safety lab tests ordered and completed at baseline and 3 months
Time Frame
index date to 180 days post-index date
Title
Change to psychotropic medication treatment plan
Description
Percentage of patients with change to psychotropic medication treatment plan following exposure to study algorithm
Time Frame
180 day period following index date
Title
Behavioral health (BH) navigation acceptance
Description
Percent of intervention arm patients that agree to BH navigation
Time Frame
180 day period following index date
Title
Use of usual care therapy
Description
Percentage of patients attending two or more system-provided therapy sessions
Time Frame
180 day period following index date
Title
Use of bridging therapy
Description
Percentage of patients attending two or more study-provided bridging therapy sessions
Time Frame
180 day period following index date
Title
Use of usual care therapy following bridging therapy
Description
Of patients in study therapy, percentage who subsequently attend two or more system-provided therapy sessions
Time Frame
180 day period following index date

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient is ≥ 3 and < 18 years of age at the time of the encounter at which the study alert fired (index date); Patient is initiating a new episode of outpatient treatment with an antipsychotic medication. (New episodes are defined by no record of an antipsychotic medication being ordered within the health system as part of an outpatient care plan in the prior 180 days); Study service (BH navigation, bridging therapy, CAP consult) ordered in Epic for the patient; (e.g., provider removed antipsychotic order and still ordered study services); Exclusion Criteria: Patient has a diagnosed psychotic disorder, mania, autism spectrum disorder, or intellectual disability; Patient was enrolled in the SUAY pilot study; The antipsychotic entered is prochlorperazine (Comazol®); An outpatient antipsychotic order is entered by a temporary provider in the health system (e.g., "doc of the day"). Orders placed by temporary providers do not count towards the 180 day medication free period for defining a new episode of care. The antipsychotic order was placed within an urgent care, emergency department, or inpatient setting (to avoid intervening during a crisis). Orders placed in these settings do not count towards the 180 day medication free period for defining a new episode of care. Primary language is not English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert B Penfold, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Colorado Institute for Health Research
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Facility Name
Nationwide Children's Hospital / Partners for Kids
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Kaiser Permanente Center for Health Research - Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Kaiser Permanente Washington Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing plan is incorporated by reference into the contract governing the project. Any changes to the plan must be pre-approved by the NIH Contracting Officer. A de-identified database will be delivered to the NIH, along with a statistical report. Any datasets for public distribution (including to the National Database for Clinical Trials Related to Mental Illness) will be de-identified in compliance with HIPAA standard for de-identification.
IPD Sharing Time Frame
A de-identified database will be delivered to the NIH on or before 12/24/2021, along with data dictionary and a study report.
IPD Sharing Access Criteria
Access to contact deliverables will be determined by NIH.
Citations:
PubMed Identifier
34256967
Citation
Penfold RB, Thompson EE, Hilt RJ, Schwartz N, Robb AS, Correll CU, Newton D, Rogalski K, Earls MF, Kowatch RA, Beck A, Yarborough BJH, Crystal S, Vitiello B, Kelleher KJ, Simon GE. Development of a Symptom-Focused Model to Guide the Prescribing of Antipsychotics in Children and Adolescents: Results of the First Phase of the Safer Use of Antipsychotics in Youth (SUAY) Clinical Trial. J Am Acad Child Adolesc Psychiatry. 2022 Jan;61(1):93-102. doi: 10.1016/j.jaac.2021.04.010. Epub 2021 May 4.
Results Reference
derived
PubMed Identifier
34143677
Citation
Chavez LJ, Kelleher KJ, Beck A, Clarke GN, Penfold RB. Trends Over Time in Antipsychotic Initiation at a Large Children's Health Care System. J Child Adolesc Psychopharmacol. 2021 Jun;31(5):381-386. doi: 10.1089/cap.2020.0190.
Results Reference
derived
PubMed Identifier
33091587
Citation
Penfold RB, Thompson EE, Hilt RJ, Kelleher KJ, Schwartz N, Beck A, Clarke GN, Ralston JD, Hartzler AL, Coley RY, Akosile M, Vitiello B, Simon GE. Safer use of antipsychotics in youth (SUAY) pragmatic trial protocol. Contemp Clin Trials. 2020 Dec;99:106184. doi: 10.1016/j.cct.2020.106184. Epub 2020 Oct 20.
Results Reference
derived
PubMed Identifier
31342851
Citation
Schoenfelder Gonzalez E, Myers K, Thompson EE, King DA, Glass AM, Penfold RB. Developing home-based telemental health services for youth: Practices from the SUAY Study. J Telemed Telecare. 2021 Feb;27(2):110-115. doi: 10.1177/1357633X19863208. Epub 2019 Jul 25.
Results Reference
derived

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Safer Use of Antipsychotics in Youth

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